Trial · NCT01272232
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
NCT01272232, Phase 3, Completed, Novo Nordisk A/S; results first posted 2015-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes. Trials, record NCT01272232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01272232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
- NCT number
- NCT01272232
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 846 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Interventions
- liraglutide, liraglutide, placebo
- First posted
- 2011-01-07
- Last updated
- 2017-12-29
- Other registries' IDs
- eudract:2008-002199-88
- Results first posted
- 2015-02-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change (%) From Baseline in Body Weight (Fasting) | Week 0, week 56 | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. |
| Primary | Proportion of Subjects Losing at Least 5% of Baseline Body Weight | at 56 weeks | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. |
| Primary | Proportion of Subjects Losing More Than 10% of Baseline Body Weight | at 56 weeks | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. |
| Secondary | Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) | Week 0, week 56 | Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56. |
| Secondary | Proportion of Subjects Reaching Target HbA1c Below 7% | at 56 weeks | |
| Secondary | Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% | at 56 weeks | |
| Secondary | Change From Baseline in Waist Circumference | Week 0, week 56 | |
| Secondary | Change (%) From Baseline in Body Weight (Fasting) | Week 0, week 68 | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. |
| Secondary | Change (%) From Week 56 to 68 in Body Weight (Fasting) | Week 56, week 68 | Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial. |
| Secondary | Change From Baseline in Waist Circumference | Week 0, week 68 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change (%) From Baseline in Body Weight (Fasting) | Week 0, week 56 | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percent change | MEAN |
| PRIMARY | Proportion of Subjects Losing at Least 5% of Baseline Body Weight | at 56 weeks | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percentage of subjects | NUMBER |
| PRIMARY | Proportion of Subjects Losing More Than 10% of Baseline Body Weight | at 56 weeks | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percentage of subjects | NUMBER |
| SECONDARY | Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) | Week 0, week 56 | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percentage point change of HbA1c | MEAN |
| SECONDARY | Proportion of Subjects Reaching Target HbA1c Below 7% | at 56 weeks | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percentage of subjects | NUMBER |
| SECONDARY | Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% | at 56 weeks | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Waist Circumference | Week 0, week 56 | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | cm | MEAN |
| SECONDARY | Change (%) From Baseline in Body Weight (Fasting) | Week 0, week 68 | Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percent change | MEAN |
| SECONDARY | Change (%) From Week 56 to 68 in Body Weight (Fasting) | Week 56, week 68 | Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | percent change | MEAN |
| SECONDARY | Change From Baseline in Waist Circumference | Week 0, week 68 | Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint. | cm | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change (%) From Baseline in Body Weight (Fasting) | Liraglutide 3.0 mg | -5.9 | Standard Deviation 5.5 | percent change | |
| Change (%) From Baseline in Body Weight (Fasting) | Liraglutide 1.8 mg | -4.6 | Standard Deviation 5.5 | percent change | |
| Change (%) From Baseline in Body Weight (Fasting) | Liraglutide Placebo | -2.0 | Standard Deviation 4.3 | percent change | |
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Liraglutide 3.0 mg | Yes | 49.9 | percentage of subjects | |
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Liraglutide 1.8 mg | Yes | 35.6 | percentage of subjects | |
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Liraglutide Placebo | Yes | 13.8 | percentage of subjects | |
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Liraglutide 3.0 mg | No | 50.1 | percentage of subjects | |
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Liraglutide 1.8 mg | No | 64.4 | percentage of subjects | |
| Proportion of Subjects Losing at Least 5% of Baseline Body Weight | Liraglutide Placebo | No | 86.2 | percentage of subjects | |
| Proportion of Subjects Losing More Than 10% of Baseline Body Weight | Liraglutide 3.0 mg | Yes | 23.4 | percentage of subjects |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Weeks 0-56 | STARTED | Liraglutide 3.0 mg | 423 | |
| Weeks 0-56 | STARTED | Liraglutide 1.8 mg | 211 | |
| Weeks 0-56 | STARTED | Liraglutide Placebo | 212 | |
| Weeks 0-56 | Exposed | Liraglutide 3.0 mg | 422 | |
| Weeks 0-56 | Exposed | Liraglutide 1.8 mg | 210 | |
| Weeks 0-56 | Exposed | Liraglutide Placebo | 212 | |
| Weeks 0-56 | COMPLETED | Liraglutide 3.0 mg | 324 | |
| Weeks 0-56 | COMPLETED | Liraglutide 1.8 mg | 164 | |
| Weeks 0-56 | COMPLETED | Liraglutide Placebo | 140 | |
| Weeks 0-56 | NOT COMPLETED | Liraglutide 3.0 mg | 99 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events309
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Liraglutide 3.0 mg | 26 | 422 | 32 |
| other | Abdominal distension | Gastrointestinal disorders | Liraglutide 1.8 mg | 10 | 210 | 11 |
| other | Abdominal distension | Gastrointestinal disorders | Liraglutide Placebo | 3 | 212 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Liraglutide 3.0 mg | 26 | 422 | 34 |
| other | Abdominal pain | Gastrointestinal disorders | Liraglutide 1.8 mg | 4 | 210 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Liraglutide Placebo | 9 | 212 | 9 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide 3.0 mg | 15 | 422 | 21 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide 1.8 mg | 14 | 210 | 17 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide Placebo | 2 | 212 | 2 |
| other | Constipation | Gastrointestinal disorders | Liraglutide 3.0 mg | 68 | 422 | 78 |
1 to 10 of 309Source ClinicalTrials.gov
See all 309 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liraglutide 3.0 mg | ||
| Total, all-cause mortality | Liraglutide 1.8 mg | ||
| Total, all-cause mortality | Liraglutide Placebo | ||
| Total, other adverse events | Liraglutide 3.0 mg | 361 | 422 |
| Total, other adverse events | Liraglutide 1.8 mg | 173 | 210 |
| Total, other adverse events | Liraglutide Placebo | 164 | 212 |
| Total, serious adverse events | Liraglutide 3.0 mg | 37 | 422 |
| Total, serious adverse events | Liraglutide 1.8 mg | 18 | 210 |
| Total, serious adverse events | Liraglutide Placebo | 13 | 212 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01272232
GET https://conductscience.org/api/trials/v1/NCT01272232/results?page=2